BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRAGG-MCNAMARA

    MDR report key: 14092902 · Received April 13, 2022

    Report

    Report Number
    2029214-2022-00618
    Event Type
    Injury
    Date Received
    April 13, 2022
    Date of Event
    July 9, 2019
    Report Date
    April 12, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CAYMAZ, I., NURILI, F., KOLCAK, O., ARAS, O., <(&)> GUMUS, B. (2020). SUCCESS AND RELIABILITY OF EXTRAFEMORAL EXOSEAL VASCULAR CLOSURE DEVICE: ¿OFF-LABEL¿ USAGE. INTERVENTIONAL MEDICINE AND APPLIED SCIENCE, 11(3), 182¿186. HTTPS://DOI.ORG/10.1556/1646.11.2019.22. A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CAYMAZ, I., NURILI, F., KOLCAK, O., ARAS, O., <(&)> GUMUS, B. (2020). SUCCESS AND RELIABILITY OF EXTRAFEMORAL EXOSEAL VASCULAR CLOSURE DEVICE: ¿OFF-LABEL¿ USAGE. INTERVENTIONAL MEDICINE AND APPLIED SCIENCE, 11(3), 182¿186. HTTPS://DOI.ORG/10.1556/1646.11.2019.22. SUMMARY: THE AIM OF THIS STUDY IS TO PRESENT THE RELIABILITY AND EFFICACY OF EXOSEAL VASCULAR CLOSURE DEVICE (EVCD) FOR CLOSURE OF E XTRAFEMORAL PUNCTURES. MATERIALS AND METHODS: ALL PATIENTS WHO WERE TREATED WITH EVCD FOLLOWING ARTERIAL ENDOVASCULAR TREATMENT INVOLVING AN EXTRAFEMORAL PUNCTURE BETWEEN APRIL 2013 AND JANUARY 2014 WERE EXAMINED RETROSPECTIVELY. THIS STUDY INCLUDED 11 PATIENTS (4 WOMEN AND 7 MEN BETWEEN THE AGES OF 48 AND 87 YEARS; AVERAGE AGE = 65 YEARS). A TOTAL OF 13 PROCEDURES WERE PERFORMED IN 11 PATIENTS INVOLVING THE FOLLOWING ACCESS ROUTES: BRACHIAL ARTERY (N = 5), POPLITEAL ARTERY (N = 4), AND POLYTETRAFLUOROETHYLENE GRAFT (N = 4). IDENTIFIED EVENTS: THE PATIENT HAD AN UNSUCCESSFUL PROCEDURE. THE HEMOSTASIS WAS MAINTAINED WITH MANUAL COMPRESSION WITHIN 5 MINUTES, HOWEVER A PROFOUND HEMATOMA (10CM IN DIAMETER) WAS OBSERVED APPROXIMATELY 12 HOURS LATER. THE HEMATOMA WAS COMPRESSED AND A BANDAGE WAS APPLIED. THE AREA OF THE HEMATOMA GREW AND AN ANGIOGRAPHY WAS PERFORMED WHERE A PSEUDOANEURYSM WAS OBSERVED. THE PSEUDOANEURYSM WAS TREATED WITH A COVERED STENT. THE PATIENT HAD A MINOR COMPLICATION WHERE THEY SUFFERED FROM ACUTE CRITICAL LIMB ISCHEMIA. THE PATIENT INITIALLY PRESENTED WITH SUDDEN COLD FEET. IN ADDITION, THE PATIENT HAD A PSEUDOANEURYSM AS WELL. THE PATIENT HAD A HISTORY OF LERICHE SYNDROME AND A BYPASS OPERATION. THE PATIENT WAS USING WARFARIN AS AN ANTICOAGULANT. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279935 CRAGG-MCNAMARA CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-CRAGG-MC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention